Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX)
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|ClinicalTrials.gov Identifier: NCT02508714|
Recruitment Status : Unknown
Verified February 2017 by Clemens von Birgelen, Thorax Centrum Twente.
Recruitment status was: Active, not recruiting
First Posted : July 27, 2015
Last Update Posted : February 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Angina Pectoris Unstable Angina Pectoris Acute Coronary Syndrome Coronary Stenosis Coronary Restenosis||Device: Orsiro Device: Resolute Onyx||Not Applicable|
rationale: The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.
The aim of the study is to compare the outcome of the bioresorbable polymer coated stent (ORSIRO) and a new generation permanent polymer coated stent (RESOLUTE ONYX) in an all-comers patient population and non-inferiority setting.
The study is a prospective, randomized, single-blinded, multicentre trial with 1:1 randomization for drug-eluting stent type, stratified for gender and the presence of diabetes mellitus.
Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included. A total of 2,470 patients will be included.
One group will receive the ORSIRO stent, the other group will receive the RESOLUTE ONYX stent. All other intervention and procedural characteristics are similar.
Primary study outcome:
Incidence of target vessel failure (TVF) at 1 year follow-up (according to ARC definitions). Components of the primary endpoint in hierarchical order: - Cardiac death: all deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established. - Target vessel related myocardial infarction (MI) that is Q-wave or non-Q-wave, that can be related to the target vessel or cannot be related to another vessel. - Clinically driven repeated target vessel revascularization by means of PCI or coronary artery bypass grafting (CABG).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2470 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)|
|Actual Study Start Date :||October 7, 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2019|
Active Comparator: Orsiro DES (Biotronik)
The ORSIRO hybrid coating DES (Biotronik, Switzerland) is a device which includes a modern, highly flexible, thin-strut stent platform, eluting sirolimus from a thin biodegradable BIO-lute coating grom PLLA (poly(L-lactic acid)) which is located mainly on the abluminal side.
stents will be implanted in case of significant coronary artery disease
Other Name: Orsiro drug eluting stent
Active Comparator: RESOLUTE ONYX DES (Medtronic)
The RESOLUTE ONYX is a permanent polymer DES that uses a novel highly flexible metallic stent backbone with increased radiographic visibility eluting the drug zotarolimus from the BioLinx durable polymer coating. The stent platform uses corewire technology that allows the stent to have a denser core metal surrounded by outer layer of cobalt-chromium.
Device: Resolute Onyx
stents will be implanted in case of significant coronary artery disease based on coronary angiography
Other Name: Resolute Onyx drug eluting stent
- Target vessel failure (TVF) [ Time Frame: 1 year ]Composite endpoint consisting of: Cardiac death (All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established); Target vessel related MI (Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel); Clinically driven repeated target vessel revascularization by means of CABG or PCI.
- Death at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]Death distinguished into: cardiac, vascular, other causes, all-cause mortality
- Myocardial infarction at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]Myocardial infarction distinguished into Q-wave and non-Q-wave myocardial infarction
- Revascularization at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]Target-vessel revascularization distinguished into PCI or CABG
- Stent thrombosis at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]Stent thrombosis was distinguished into definite, probable and possible according to the Academic Research Consortium (ARC) definition.
- Target lesion failure (TLF) at 1 and 2 year follow-up [ Time Frame: 1 and 2 year ]Composite endpoint consisting of : cardiac death; target vessel-related MI; clinically driven target lesion revascularization (TLR)
- Major adverse cardiac events (MACE) at 1 and 2 year follow-up [ Time Frame: 1 and 2 year follow-up ]
Composite endpoint consisting of:
- any death;
- any myocardial infarction
- emergent CABG;
- clinically indicated TLR
- Patient oriented composite endpoint (POCE) at 1 and 2 year follow-up [ Time Frame: 1 and 2 year follow-up ]Composite endpoint consisting of: any death; any myocardial infarction; any revascularization.
- Major Bleeding at 1 and 2 year follow-up [ Time Frame: 1 and 2 year follow-up ]Major bleeding that require surgery or blood transfusions or cerebral hemorrhages
- Longitudinal stent deformation (LSD) and deliverability [ Time Frame: 1 year ]Identification of deformation of a stent in the longitudinal axis during coronary angiographic assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508714
|Den Haag, Zuid Holland, Netherlands, 2504 LN|
|Medisch Spectrum Twente|
|Principal Investigator:||Clemens von Birgelen, MD, PhD||Thorax Centrum Twente|